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Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

NCT06218303 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-12

No results posted yet for this study

Summary

Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.

Conditions

  • Ductal Carcinoma in Situ

Interventions

BIOLOGICAL

MUC1 Peptide Vaccine

MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.

DRUG

Hiltonol®

A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.

DRUG

Aromatase Inhibitor

A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.

DRUG

Selective estrogen receptor modulator (SERM)

A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.

Sponsors & Collaborators

  • A Glimmer of Hope Foundation

    collaborator UNKNOWN

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Finn, Olivera, PhD

    lead OTHER

Principal Investigators

  • Emilia Diego, MD · UPMC Magee Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2026-08-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218303 on ClinicalTrials.gov